Deadline extended to 10 October 2022, 12PM CEST
The World Health Organization (WHO), is seeking feedback on the attached technical specifications for prequalification of Blood pressure measurement devices (BPMD). The call is opening 1 September 2022.
The document aims to provide technical guidance to medical device manufacturers that intend to seek WHO prequalification (PQ) of BPMD. The document includes the technical specifications for non-invasive BPM devices. The scope of the publication will only focus on automated and semi-automated non-invasive upper-arm BPMDs with cuffs for use in adults.
The intended use of the BPM is as follows:
Automated professional office devices, home use for clinical evaluation of BP; and
Automated ambulatory (ABPM) devices for the clinical evaluation of BP
The BPMD for a child, neonates and critical care settings are excluded from this scope.
Comments can be submitted to medicaldevices@who.int using the following form.